Bombay HC pulls up Maharashtra FDA for enforcement action: What businesses need to know | Today’s news
The Bombay High Court’s scrutiny of Maharashtra’s Food and Drug Administration (FDA) has widened in recent months, with the court examining whether the regulator’s treatment of businesses was reasonable and followed due process.
The latest case involves Cipla Pharma & Life Sciences, but the court’s interventions have also involved restaurants, hotels, patisseries, dairies and pharmaceutical companies, according to a report by CNBC-TV18.
The court’s review focused on the FDA’s conduct and the circumstances surrounding each enforcement action, rather than challenging the regulator’s authority to enforce food and drug safety standards.
The Cipla case
On August 29, the Bombay High Court challenged the Maharashtra FDA’s cancellation of wholesale drug licenses associated with Cipla Pharma & Life Sciences’ primary distribution facility at Wadki in Pune.
The FDA took action following inspections that pointed to alleged irregularities involving Reactin Plus tablets. The observations included problems with packaging and artwork, discrepancies between physical and computerized inventory records, gaps in purchase and sale records, and concerns about the tablets being recalled.
Cipla contested the cancellation, claiming he was not given an adequate opportunity to be heard.
According to the proceedings reported by the Bar & Bench, the FDA issued a show cause notice on August 13 to which Cipla responded on August 25. An in-person hearing was scheduled for August 26, which was a public holiday. After Cipla applied for an adjournment, the authority proceeded with the cancellation decision.
The High Court questioned the procedure and called the suit “fraudulent”. The FDA subsequently agreed to withdraw the cancellation order and issue a new notice, giving Cipla an opportunity to respond before making a new decision.
The bench also advised the FDA to avoid scheduling hearings on public holidays unless there is a genuine emergency.
Read also | Cipla Pharma license cancellation: FDA withdraws order after HC raps it for going ‘overboard’
FDA action against MCA restaurants
A separate case involving five restaurants operating on the premises of the Mumbai Cricket Association in BKC also resulted in a strong remark from the apex court.
According to a News18 report, a union bench headed by Chief Justice Ravindra Ghuge and Justice Gautam Ankhad lifted the FDA’s suspension orders and allowed the outlets to reopen.
The FDA cracked down on the restaurants for alleged sanitation violations and problems related to their third-party operation. The food licenses were held in the name of MCA while the FDA claimed that the establishments were being run by M/s Shirke Infrastructure.
During the proceedings, the court asked the FDA to take a pragmatic approach. The department continued the suspension after a new inspection found the restaurants to be 88% in compliance with food safety requirements.
The court criticized the FDA for taking what it described as a “pedantic rather than pragmatic” approach and warned officials against possible contempt.
Read also | “Do you feel that you are a master?” Bombay HC withdraws FDA
Other cases under the scrutiny of the court
The Supreme Court has also intervened in several other cases involving the Maharashtra FDA.
In the case of Gurunanak Dairy and Sweets in Pune, the FDA suspended the business’s license after a food poisoning incident. A subsequent inspection found the business to be 98% compliant, but the suspension remained in place. The Supreme Court lifted the suspension and ordered the FDA to pay ₹5 million in compensation for the company.
In another case involving the Park Inn by Radisson in Navi Mumbai, the hotel challenged the FDA’s license suspension following an inspection that raised hygiene concerns. The High Court subsequently reinstated the license and examined whether the deficiencies warranted the continuation of the suspension.
The Aurangabad bench of the Bombay High Court in July also stayed FDA action against milk sellers and suppliers. The proceedings raised questions about whether the statutory procedure, including notice of improvement and opportunity for a hearing, had been followed prior to the suspension.
The regulator’s powers have also come under scrutiny in the Cadila Pharmaceuticals case, where the high court examined the practice of halting the sale and distribution of certain drugs and whether the FDA exercised its powers properly.
Court not against FDA enforcement
Recent cases do not suggest that the Bombay High Court has taken a blanket stance against the FDA’s action. In a case involving Udupi Swaad, a Thane restaurant whose license was suspended after FDA officials found it was serving analogue paneer, the court refused to grant urgent interim relief against the regulatory action.
The mixed results show that the court’s interventions depended on the circumstances of each case, including the nature of the alleged breach and the regulator’s course of action.
Why cases matter to businesses
The ruling raised several issues that may become important when an FDA action is challenged.
Businesses may ask whether they were given a reasonable opportunity to respond, whether the alleged breach warranted an immediate suspension or revocation, whether follow-up remedial action was considered, and whether the regulator gave sufficient reasons for its decision.
The development comes as the Maharashtra FDA has stepped up inspections and enforcement against restaurants, food companies, dairies and other establishments since Tukaram Mundhe took over as FDA commissioner three months ago.
